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Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.

Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03138278
Acronym
VIP2
Enrollment
0
Registered
2017-05-03
Start date
2023-05-31
Completion date
2024-12-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers, Depression, Anxiety, Functionally-Impaired Elderly, Intensive Care Unit Syndrome, PTSD

Brief summary

It is known from extensive documentation that second victims in critical illness often are the care givers of the patients: family, friends or other persons. Although this has not been specifically studied in the very old patients, there is no reason to believe that this group will be different from other ICU patients. Even more so, in this very old age patient group there are seldom any older relatives. Partners, like wife/husband or other cohabitants, may be dead or themselves incapacitated. Many will be in institutional care. The closest care-givers will be middle-aged people such as children or others, if no partners are available. The hypothesis is that critical illness can be a large stressor to care-givers of survivors in the VIP measured as the occurrence and severity of the usual problems like PTSD and depression. The investigators hypothesize that a low-threshold on-line support program decreases the magnitude of anxiety, depression and PTSD for care-givers of very old intensive care patients (VIP) after discharge.

Detailed description

Aims of the study * Results from family/care givers experience: Degree of involvement with post-ICU care, impact on their own health (depression, PTSD, burden questionnaire) * Effect of a simple intervention: on-line support and/or telephone advice on Return to pre-ICU frailty score (patients) and Occurrence of PTSD and depression in care-givers * Information on 6 months' outcome (frailty and mortality) in very old survivors after ICU in different European countries * Information on trajectories in the time after discharge: Dead/alive, home, nursing home, new hospital admissions, living with family/other care-givers, etc.

Interventions

OTHERTelephone support on demand

Dedicated phone number for help and advice for caregivers

Sponsors

European Society of Intensive Care Medicine
CollaboratorOTHER
University of Bergen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Multicentre study with ≥ 100 ICUs from Europe. Randomisation at ICU level to give support to caregivers or not (cluster-randomisation)

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospital survivors after any ICU admission

Exclusion criteria

* Imminent terminal care

Design outcomes

Primary

MeasureTime frameDescription
Burden scale for Family Caregiver6 months post ICU dischargeIn order to assess the burden of care the investigaors will use an European questionaire developed within the EU and freely available online: Assessment of subjective burden of informal caregivers (http://www.psychiatrie.uk-erlangen.de/index.php?id=11049/) available in 20 European languages
Post traumatic stress (PTSD) in caregivers6 months post ICU dischargeThe study will use PTSD questionnaire PTSS-14 as described at www.sthk.nhs.uk/library/documents/7308450\_ptss14.pdf.
Anxiety and Depression in caregivers6 months post ICU dischargeThe investigators will use the Hospital anxiety and depression scale, a questionaire often used out of hospital as well. It is a simple questionaire that will be delivered to the care-givers after 6 months.

Secondary

MeasureTime frameDescription
6 months survival in the elderly ICU survivors6 months post ICU dischargeTime of death in non-survivors (patients) will be sought through administrative hospital data (when available) or from care-givers
Trajectories in the elderly ICU survivors6 months post ICU dischargeThe investigators will seek to describe where the patients have been after hospital discharge: like rehabilitation facilities, nursing home, togehter with care-givers or in their own home.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026